Enhanced treatment regimens using mTOR inhibitors

Abstract

The present invention provides for methods and pharmaceutical compositions comprising inhibitors of mTorC1 and/or mTorC2. In some aspects, the invention provides for treatment regimens resulting in enhanced treatment efficacy and better tolerability.

What is claimed is: 
     
       1. A dosage form comprising a therapeutically effective amount of an mTorC1/mTorC2 inhibitor for administration to a subject in need thereof, wherein the dosage form is formulated to provide a Cmax of greater than about 200 nM to the subject, and wherein the mTorC1/mTorC2 inhibitor is 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
       2. The dosage form of  claim 1 , wherein the therapeutically effective amount of an mTorC1/mTorC2 inhibitor is about 45, 50, 55, 60, 70, 75 mg or less. 
     
     
       3. The dosage form of  claim 2 , wherein the dosage form provides a plasma concentration of said mTorC1/mTorC2 inhibitor greater than about 100 nM for at least about 20 hours during a 7-day period of administration. 
     
     
       4. The dosage form of  claim 2 , wherein the dosage form provides a plasma concentration of said mTorC1/mTorC2 inhibitor greater than about 100 nM for at least about 30 hours during a 7-day period of administration. 
     
     
       5. The dosage form of  claim 2 , wherein the mTorC1/mTorC2 inhibitor is administered parenterally, orally, intraperitoneally, intravenously, intraarterially, transdermally, intramuscularly, liposomally, via local delivery by catheter or stent, subcutaneously, intraadiposally, or intrathecally. 
     
     
       6. The dosage form of  claim 2 , wherein the mTorC1/mTorC2 inhibitor is administered orally. 
     
     
       7. The dosage form of  claim 2 , wherein the dosage form is capsule, tablet, pill, powder, solution, or suspension. 
     
     
       8. The dosage form of  claim 1 , wherein the subject is a cancer patient. 
     
     
       9. The dosage form of  claim 8 , wherein the cancer is renal cancer, renal cell carcinoma, colorectal cancer, uterine sarcoma, endometrial uterine cancer, endometrial cancer, breast cancer, ovarian cancer, cervical cancer, gastric cancer, fibrosarcoma, pancreatic cancer, liver cancer, melanoma, leukemia, myeloma, nasopharyngeal cancer, prostate cancer, lung cancer, glioblastoma, bladder cancer, mesothelioma, head cancer, or neck cancer. 
     
     
       10. The dosage form of  claim 8 , wherein the cancer is renal cancer. 
     
     
       11. The dosage form  claim 8 , wherein cancer is renal cell carcinoma. 
     
     
       12. The dosage form of  claim 8 , wherein the cancer is ovarian cancer. 
     
     
       13. The dosage form of  claim 8 , wherein the cancer is breast cancer. 
     
     
       14. The dosage form of  claim 8 , wherein the cancer is uterine sarcoma. 
     
     
       15. The dosage form of  claim 8 , wherein the cancer is endometrial uterine cancer. 
     
     
       16. The dosage form of  claim 8 , wherein the cancer is cervical cancer. 
     
     
       17. The dosage form of  claim 8 , wherein the cancer is gastric cancer.